(88 days)
The Smart Fit Knee 3.0T coil is designed to be used in conjunction with a Philips 3.0T MR system to produce diagnostic images of the Knee that can be interpreted by a trained physician.
The Smart Fit Knee 3.0T coil is designed to be used in conjunction with a Philips 3.0T MR system to produce diagnostic images of the Knee that can be interpreted by a trained physician.
The Smart Fit Knee 3.0T is a 16-element coil designed for high-resolution imaging of the left or right knee. It is a phased-array, Rx volume coil providing an integrated solution with a base plate, an anterior and a posterior part. Positioning pads are also supplied to support comfortable positioning. The coil can be slightly rotated relative to its base plate to ease coil setup and enhance patient comfort. The coil is used independently and cannot be combined with any other coils. This coil is available for 3.0T MR systems and is compatible with Philips 3.0T MR Scanners.
The provided text describes the Philips Smart Fit Knee 3.0T MRI coil, but it does not contain acceptance criteria for device performance or a detailed study proving the device meets specific performance criteria through clinical effectiveness measures.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (HRK-127-8 KNEE ARRAY COIL K033567) for regulatory clearance. This is primarily done through technological comparisons and compliance with recognized consensus standards.
Here's a breakdown of the information available and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for clinical effectiveness. The acceptance criteria in this document are implicitly related to compliance with recognized standards and showing similarity to the predicate device in design, intended use, and fundamental scientific technology.
- Reported Device Performance:
- "The performance test results demonstrate that the proposed Smart Fit Knee 3.0T meets the acceptance criteria and is adequate for its intended use." This is a general statement of compliance, not a report of specific numerical performance metrics.
- "All clinical images on the proposed coils Smart Fit Knee 3.0T were evaluated by qualified radiologists. No issues with the clinical image quality were seen and images were considered have sufficient quality for diagnostic use." This broadly indicates acceptable image quality based on expert review, but no quantifiable performance metrics (e.g., sensitivity, specificity, SNR values) are provided.
Table based on available information (focused on equivalence and general performance):
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Compliance with relevant IEC, ISO, AAMI, NEMA standards. | Meets ANSI AAMI ES60601-1, IEC60601-2-33, IEC60601-1-2, IEC60601-1-6, ISO 14971, IEC 62366-1, ANSI AAMI ISO10993-1, NEMA MS 1, NEMA MS 3, NEMA MS 9, NEMA MS 14 (list of standards provided in the Summary of Non-Clinical Performance Data). |
| Image quality sufficient for diagnostic use. | Evaluated by qualified radiologists; no issues with clinical image quality were seen; images considered to have sufficient quality for diagnostic use. |
| Biocompatibility with intact human skin exposure < 24h. | Biocompatibility testing performed against ISO10993-1; materials (PC and PU) safety proved in biocompatibility report. |
| Similar fundamental scientific technology to predicate device. | Phased-array Receive only coil, Head-Feet oriented (B0) magnetic field, 127.728MHz+/-0.75MHz frequency range, Overlap/pre-amp decouple/Active/Passive PIN diode decoupling, derived from MR scanner energy source. |
| No new risks or sufficiently mitigated risks. | Risk management activities show all risks are sufficiently mitigated, no new risks introduced, and overall residual risks are acceptable. |
2. Sample size used for the test set and the data provenance:
- The document states that "All clinical images on the proposed coils Smart Fit Knee 3.0T were evaluated," but it does not specify the sample size (number of patients or knee images) for this clinical image quality evaluation test set.
- Data Provenance: Not explicitly stated. Given that Philips Healthcare (Suzhou) Co., Ltd. is based in China, and the contacts appear to be from China and the Netherlands, the images could originate from various countries where Philips systems are used. The document does not specify if the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not specified beyond "qualified radiologists."
- Qualifications of experts: Only stated as "qualified radiologists." No specific details such as years of experience, subspecialty (e.g., musculoskeletal radiologist), or board certification are provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document mentions that clinical images were "evaluated by qualified radiologists." It does not specify an adjudication method (e.g., how disagreements were resolved if multiple radiologists reviewed the same images). It might imply a consensus reading or individual review without further adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. The document explicitly states: "The proposed Smart Fit Knee 3.0T did not require clinical study since substantial equivalence to the legally marketed predicate device was demonstrated in comparison."
- This device is an MRI coil, a hardware component, not an AI-powered diagnostic algorithm. Therefore, "human readers improve with AI vs without AI assistance" is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is an MRI coil, not an algorithm. Performance is assessed on its ability to produce diagnostic images, which are then interpreted by humans.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For image quality, the ground truth was expert opinion/review by qualified radiologists. Their determination that "No issues with the clinical image quality were seen and images were considered have sufficient quality for diagnostic use" served as the basis for performance.
8. The sample size for the training set:
- Not applicable. This device is a passive MRI coil (hardware). It does not involve machine learning algorithms that require a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this hardware device.
In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence of a new MRI coil to a predicate device, primarily through non-clinical testing for compliance with standards and a general statement about image quality review by radiologists, rather than a clinical study with detailed performance metrics and ground truth establishment as would be expected for an AI/software device.
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February 5, 2024
Philips Healthcare (Suzhou) Co., Ltd. Sherry Li Regulatory Affairs Specialist No. 258, Zhongyuan Road, Suzhou Industrial Park Suzhou, Jiangsu 215024 China
Re: K233600
Trade/Device Name: Smart Fit Knee 3.0T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: November 3, 2023 Received: November 9, 2023
Dear Sherry Li:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Smart Fit Knee 3.0T
Indications for Use (Describe)
The Smart Fit Knee 3.0T coil is designed to be used in conjunction with a Philips 3.0T MR system to produce diagnostic images of the Knee that can be interpreted by a trained physician.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| DatePrepared: | November 09, 2023 | |||
|---|---|---|---|---|
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd. | |||
| No. 258, Zhongyuan Road, Suzhou Industrial Park, Suzhou Jiangsu, CHINA, 215024 | ||||
| Establishment Registration Number: 3009529630 | ||||
| PrimaryContactPerson: | Sherry Li | |||
| Regulatory Affairs Specialist | ||||
| Phone: +86-0512-67336833 | ||||
| E-mail: sherry.li@philips.com | ||||
| SecondaryContactPerson | Leo Louis | |||
| Regulatory Affairs Director | ||||
| Phone: +31 (6) 87945888 | ||||
| E-mail: leo.louis@philips.com | ||||
| Device Name: | Smart Fit Knee 3.0T | |||
| Classification: | Classification name: | Magnetic Resonance Diagnostic Device | ||
| Classification Regulation: | 21CFR 892.1000 | |||
| Classification Panel: | Magnetic Resonance Diagnostic Device | |||
| Device Class: | Class II | |||
| Primary Product Code: | MOS | |||
| PredicateDevice forSmart Fit 3.0T | Trade name: | HRK-127-8 KNEE ARRAY COIL | ||
| Manufacturer: | MRI Devices Corporation, 1515 Paramount Drive,Waukesha, Wisconsin 53186, U.S.A. | |||
| 510(k) Clearance: | K033567 | |||
| Classification Regulation: | 21CFR 892.1000 | |||
| Classification name: | Magnetic Resonance Diagnostic Device | |||
| Classification Panel: | Radiology | |||
| Device class | Class II | |||
| Product Code: | MOS | |||
| Device Description: | The Smart Fit Knee 3.0T coil is designed to be used in conjunction with a Philips 3.0T MR system toproduce diagnostic images of the Knee that can be interpreted by a trained physician.The Smart Fit Knee 3.0T is a 16-element coil designed for high-resolution imaging of the left or rightknee. It is a phased-array, Rx volume coil providing an integrated solution with a base plate, ananterior and a posterior part. Positioning pads are also supplied to support comfortable positioning.The coil can be slightly rotated relative to its base plate to ease coil setup and enhance patientcomfort.The coil is used independently and cannot be combined with any other coils. This coil is available for3.0T MR systems and is compatible with Philips 3.0T MR Scanners. | |||
| Indications for Use: | The Smart Fit Knee 3.0T coil is designed to be used in conjunction with a Philips 3.0T MR systemto produce diagnostic images of the Knee that can be interpreted by a trained physician. | |||
| Substantial Equivalence: | The 510(k) summary contains a summary of the technological characteristics of the proposed SmartFit Knee 3.0T compared to the predicate devices HRK-127-8 KNEE ARRAY COIL (K033567). | |||
| Table 1 | ||||
| Comparison of the primary currently marketed and predicate device, HRK-127-8 KNEE ARRAYCOIL versus the proposed Smart Fit Knee 3.0T | ||||
| Proposed Device, Smart Fit Knee 3.0T | Primary Currently Marketed and Predicate Device, HRK-127-8 KNEE ARRAY COIL | Conclusion | ||
| Design features | ||||
| Appearance | Image: Smart Fit Knee 3.0T | Image: HRK-127-8 KNEE ARRAY COIL | Similar.The differences in appearance between products are notexpected to trigger a clinically significant difference inclinical performance or safety of the device. | |
| Coil DimensionsLength XWidth XHeight | LXWXH = 538 X 280 X 293mm | LXWXH = 300 X 250 X 285mm | Similar.Smart Fit Knee 3.0T isdesigned to be assembled ona baseplate, so it's larger. Thedifferences in appearance between products are notexpected to trigger a clinically significant difference inclinical performance or safety of the device. | |
| Type of coil | Phased-array Receive only coil | Phased-array Receive only coil | Same. | |
| Number of Channels / | 16 Channels, 16 Preamplifiers | 8 Channels, 8 Preamplifiers for | Similar. | |
| Preamplifiers | Trio 3.0T System.6 Channels, 8 Preamplifiers forPhilips Intera 3.0T system. | The differences in number ofchannels and preamplifiersbetween products are notexpected to trigger a clinicallysignificant difference inclinical performance or safetyof the device. | ||
| SystemConnector /Compatibilityand coilconnector | Analogue connector mating facewith dStream Interface 3.0T whichhas a DCI connector mating facewith system. | Has a standard coil connectorto connect the coil directly toan MRI system. | Similar.The differences betweenproducts are not expected totrigger a clinically significantdifference in clinicalperformance or safety of thedevice. | |
| Applicationsite / bodypart | Knee. | Knee. | Same. | |
| Patientpopulation | Philips Rx coils are intended for anypatient who requires an MRexamination, and for whom the useof the coil provides an additionaldiagnostic benefit (in terms of Fieldof View or Signal-to-noise ratio)according to the clinical user.Exceptions to admissible patientsrelate to their physicalcharacteristics (circumference,mass) in relation to coil dimensions. | Intended for use on the orderof a physician, in conjunctionwith a magnetic resonance(MR) scanner, as an accessoryto produce images of theanatomy of interest, as an aidto diagnosis/ treatment. | Same.Although the wording isdifferent, the meaning is thesame. No difference incharacteristics betweenproducts. | |
| Intended Use | ||||
| Intended use | Philips Magnetic Resonance (MR)Receive-only (Rx) coils are intendedto be used in conjunction with aPhilips MR-system to enabletrained physicians to obtain cross-sectional images of the internalstructure of the head, body, orextremities, in any orientation.These images, when interpreted bya trained physician, provideinformation that may assistdiagnosis and therapy planning. | To be used in conjunction witha Magnetic ResonanceScanner to produce diagnosticimages of the knee that canbe interpreted by a trainedphysician. | Same.Although the wording isslightly different the meaningis the same. No difference incharacteristics betweenproducts. | |
| Fundamental Scientific Technology | ||||
| Type of coil | Phased-array Receive only coil | Phased-array Receive only coil | Same. | |
| MagneticFieldOrientation | Head-Feet oriented | Head-Feet oriented | Same. | |
| (B0) | ||||
| Frequencyrange | 127.728MHz+/-0.75MHz | 127.728MHz+/-0.75MHz | Same. | |
| Decouplingmethod | Overlap, pre-amp decouple,Active/Passive PIN diodedecoupling | Overlap, pre-amp decouple,Active/Passive PIN diodedecoupling | Same. | |
| Energy source | Derived from MR scanner, nointernal energy source | Derived from MR scanner, nointernal energy source | Same. | |
| HousingMaterial | PC and PU. | Plastic. | Similar.PC is also a type of plastic. Thesafety of PC and PU has beenproved in the biocompatibilityreport. The differencesbetween products are notexpected to trigger a clinicallysignificant difference inclinical performance or safetyof the device. | |
| Base Pad | PCB | PCB | Same. | |
| Principle ofoperation | The coil receives magneticresonance signals generated inhydrogen nuclei (protons) in thehuman body while blocking theradio frequency magnetic fieldapplied by the MRI system atspecified timings. The receivedsignal is amplified and transmittedto the MRI system, where it isprocessed into tomographic imagesby the computer. | The coil receives magneticresonance signals generatedin hydrogen nuclei (protons)in the human body whileblocking the radio frequencymagnetic field applied by theMRI system at specifiedtimings. The received signal isamplified and transmitted tothe MRI system, where it isprocessed into tomographicimages by the computer. | Same. | |
| Biological characteristics | Philips MR RF Rx coils are non-invasive surface devices that are only in contact with covered and/or intact patient skinwith limited exposure (<24h). Biocompatibility testing against internal specifications and requirements of theISO10993-1 has been performed. Further details can be found in the Biocompatibility Report. | |||
| Materials orsubstances incontact withwhich humantissues orbody fluids* | Intact skin. | Intact skin. | Same. | |
| Kind andduration ofcontact withwhich human | Coils are in contact with coveredand/or intact skin with limitedexposure < 24h. | Coils are in contact withcovered and/or intact skinwith limited exposure < 24h. | Same. | |
| tissues orbody fluids | ||||
| Releasecharacteristicsof substances,includingdegradationproducts andleachables | Due to the nature of body contactof Rx coils, degradation is notconsidered a recommendedendpoint for consideration ofbiocompatibility. | Due to the nature of bodycontact of Rx coils,degradation is not considereda recommended endpoint forconsideration ofbiocompatibility. | Same. | |
| * The characteristic must be the same for the demonstration of equivalence | ||||
| Based on the information provided above, Smart Fit Knee 3.0T are considered substantial equivalentto the primary currently marketed and predicate device HRK-127-8 KNEE ARRAY COIL (K033567). | ||||
| Summary ofNon-ClinicalPerformanceData: | The proposed Smart Fit Knee 3.0T complies with the following international and FDA-recognizedconsensus standards:ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons.Text) [Incl. AMD2:2021]Medical electrical equipment - Part 1: General requirements for basicsafety and essential performanceFDA/CDRH recognition number 19-46 IEC60601-2-33 Ed. 3.2:2015 Medical electrical equipment - Part 2-33: Particular requirements forthe basic safety and essential performance of magnetic resonance equipment for medicaldiagnosisFDA/CDRH recognition number 12-295 IEC0601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral standard:Electromagnetic disturbances - Requirements and testsFDA/CDRH recognition number 19-36 IEC60601-1-6:2010/AMD2:2020 Medical electrical equipment - Part 1-6: General requirementsfor basic safety and essential performance - Collateral standard: UsabilityFDA/CDRH recognition number 5-132 ISO 14971 Ed. 3:2019 Medical devices - Application of risk management to medical devices.FDA/CDRH recognition number 5-125. IEC 62366-1:2015/AMD1:2020 - Medical devices Part 1: Application of usability engineering tomedical devicesFDA/CDRH recognition number 5-129 ANSI AAMI ISO10993-1:2018 – Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management processFDA/CDRH recognition number 2-258 NEMA MS 1-2008(R2020)Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance ImagingFDA/CDRH recognition number 12-188 NEMA MS 3-2008 (R2020)Determination of Image Uniformity in Diagnostic Magnetic Resonance ImagesFDA/CDRH recognition number 12-187 |
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PHII 1
| • NEMA MS 9-2008 (R2020) Characterization of Phased Array Coils for Diagnostic MagneticResonance Images | |
|---|---|
| FDA/CDRH recognition number 12-288 | |
| • NEMA MS 14-2019 Characterization of Radiofrequency (RF) Coil Heating in MagneticResonance Imaging Systems | |
| FDA/CDRH recognition number 12-331 | |
| The performance test results demonstrate that the proposed Smart Fit Knee 3.0T meets theacceptance criteria and is adequate for its intended use. Additionally, the risk management activitiesshow that all risks are sufficiently mitigated, that no new risks are introduced, and that the overallresidual risks are acceptable. | |
| Based on the supporting data provided in this 510(k) submission, the proposed Smart Fit Knee 3.0Tare considered substantially equivalent to the currently marketed and predicate device HRK-127-8KNEE ARRAY COIL (K033567). | |
| Summary ofClinical Data: | The proposed Smart Fit Knee 3.0T did not require clinical study since substantial equivalence to thelegally marketed predicate device was demonstrated in comparison. |
| All clinical images on the proposed coils Smart Fit Knee 3.0T were evaluated by qualifiedradiologists. No issues with the clinical image quality were seen and images were considered havesufficient quality for diagnostic use. |
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.